VIBIM Study: One-year results of treatment of DME with aflibercept using TnE
Reviewed by Sofia Rokerya

The VIBIM study (the treat-and-extend regimen (TER) using intravitreal aflibercept in diabetic macular edema (DME) study) was designed to evaluate the efficacy of the TER using aflibercept in the management of DME for a period of two years. The authors present the results of the one-year interim analysis of this prospective, multicentre, interventional, single arm study. The eyes received five consecutive intravitreal injections of 2mg of aflibercept every four weeks, and the interval between injections was then adjusted by two weeks based on changes in the central subfield macular thickness (CSMT). This adjustment was done using a threshold of 10% change (decrease or increase) in CSMT compared to that of the previous visit. During the loading phase, a patient was allowed to enter the TnE phase if the CSMT was <250μm and the Snellen VA was 20/20 before the five consecutive injections. During the TnE phase, if the CSMT was stable for two consecutive visits and the interval between visits had been extended to the maximum of 12 weeks, the treatment was deferred and the next interval was shortened to eight weeks. If there was no worsening of DME, the patient was observed without treatment at eight-week intervals. The interval was shortened (minimum four weeks), extended or maintained (maximum 12 weeks). The primary outcome measure was the change in best-corrected visual acuity (BCVA) from baseline to 104 weeks, and the secondary outcome was the change in BCVA from baseline to 52 weeks. Of the 48 patients enrolled, 46 (23 males and 23 females) completed a one-year visit. The mean age of included subjects was 59.4 ±12.4 years. Mean duration of diabetes was 16.6 ±8.5 years, and 20 patients (43.5%) were treatment-naïve. BCVA improved significantly by 9.1 letters (95% confidence interval: 5.3-13.0 letters) from 56.2 letters at baseline (p<0.001), and CSMT decreased by –171.7μm from 489.4 to 317.7μm (p<0.001). The proportion of eyes having 20/40 or better vision increased from 17.4 to 41.3%, and the proportion of eyes that gained ≥15 letters was 28.3%. The mean number of injections was 8.5 times for 52 weeks. Worsening of macular oedema did not occur in 76.1% of eyes during the extension period, and the interval between injections was extended to 12 weeks in 73.9% of eyes at 52 weeks. The TER showed one-year efficacy comparable to that of the fixed dosing regimen of pivotal trials and its flexible dosing would prevent overtreatment. The study is currently ongoing and in its second year. Limitations: Single-arm study without a control group. The number of cases was relatively small compared with pivotal studies.

One-year results of treatment of diabetic macular edema with aflibercept using the treat-and-extend dosing regimen: the VIBIM Study.
Pak KY, Shin JP, Kim HW, et al.
OPHTHALMOLOGICA
2020;243:255-62.